Opportunity Title: IMEDS-Methods Research Agenda Offering Agency: Food and Drug Administration CFDA Number: 93.103 CFDA Description: Food and Drug Administration_Research Opportunity Number: RFA-FD-15-010 PI Name: Susan Gruber Project Title: IMEDS-Methods Research Agenda Abstract: IMEDS-Methods is a program within the Reagan-Udall Foundation (RUF) that supports the FDA?s scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases. IMEDS-Methods aims to improve the tools for conducting post- marketing safety surveillance using automated healthcare data and to foster their adoption. In meeting this mission, IMEDS-Methods also adds to the general body of knowledge for using automated health data for broader post-market evidence generation on regulated products.1 The overarching goal of the IMEDS-Methods Program is to reduce uncertainty in the FDA?s ongoing evaluation of marketed medical products. Projects on the IMEDS-Methods 2015 Research Agenda are geared towards improving our ability to use electronic healthcare data to inform regulatory decision- making. IMEDS plans to fund projects in five core areas: (1) addressing bias in estimates from observational studies; (2) better understanding uses and limitations of the data; (3) applying lessons learned from earlier IMEDS projects to FDA surveillance activities; (4) expanding the surveillance question to continuous Risk/Benefit assessment; and (5) continuing to support qualified investigators in industry, government, and academic settings by providing access to de-identified electronic healthcare data and computing resources through the IMEDS Research Laboratory. Enhancements to the IMEDS Research Lab include developing novel tools and additional data sources to investigators in the research community. 1 Innovation in Medical Evidence Development and Surveillance (IMEDS) Charter. http://www.reaganudall.org/our-work/safety- and%20better-evidence/imeds-program/imeds-charter/ accessed September 30, 2013. First Draft Completed: April 2013 Proposed Revised Draft: August 2013; Section 3.1